ApprovalTrail

Approval · Notice of Compliance 32088 · 2023

IPG-MODAFINIL: Notice of Compliance 32088

Issued November 14, 2023

A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.

Notice number
32088
Date
November 14, 2023
Company
Marcan Pharmaceuticals Inc.Ottawa, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to an Abbreviated New Drug Submission (SANDS), supplement
Submission class
Other
Reason
Addition of a manufacturing site of the drug product. Changes to manufacturing process. Alternate drug substance manufacturing site. Update to the Product Monograph
Canadian reference product
ALERTEC (Teva Canada Limited)

Products in this notice

BrandDINStatus today
IPG-MODAFINILNot yet assigned—

Medicinal ingredients